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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K161770
Device Name Rusch Silicone Foley Catheter
Applicant
Teleflex Medical, Inc.
2917 Weck Drive
Research Triangle Park,  NC  27709
Applicant Contact Lori Pfohl
Correspondent
Teleflex Medical, Inc.
2917 Weck Drive
Research Triangle Park,  NC  27709
Correspondent Contact Lori Pfohl
Regulation Number876.5130
Classification Product Code
EZL  
Date Received06/28/2016
Decision Date 05/05/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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